Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the
immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate
the white blood cells, including lymphokine-activated killer cells, to kill tumor cells.
Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in
treating patients with glioblastoma multiforme.
OBJECTIVES:
- Determine the feasibility, side effects, and toxicity associated with intracranial
cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated
killer cells in patients with glioblastoma multiforme.
- Determine progression-free and overall survival of these patients.
- Compare survival of these patients to that of contemporary and historical controls.
OUTLINE: Patients undergo therapeutic craniotomy.
Patients undergo leukapheresis to obtain lymphokine-activated killer (LAK) cells 3-7 days
before therapeutic craniotomy OR 4-6 weeks after therapeutic craniotomy. Patients receive
cellular adoptive immunotherapy comprising aldesleukin-stimulated LAK cells intracranially
at the time of therapeutic craniotomy OR via an Ommaya reservoir (placed during craniotomy)
no sooner than 4-6 weeks after therapeutic craniotomy.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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